Events

Recall of Device Recall Imbibe Aliquot Needle Bone Cement Needle

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Orthovita, Inc., dBA Stryker Orthobiologics..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69979
  • Event Risk Class
    Class 2
  • Event Number
    Z-0937-2015
  • Event Initiated Date
    2014-12-04
  • Event Date Posted
    2015-01-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132062
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Instrument, Biopsy - Product Code KNW
  • Reason
    There is the potential for a breach in the inner or outer packaging pouches of all lots of the stryker orthobiologics imbibe aliquot needle bone cement needle.
  • Action
    The firm, Stryker, sent an "URGENT PRODUCT RECALL" letter dated December 4, 2014, to end users/customers. The letter identified the product, problem, and actions to be taken. Customers were instructed to complete and return the URGENT MEDICAL DEVICE RECALL NOTIFICATION ACKNOWLEDGMENT FORM within 5 days via fax to 215-253-5020, contact other hospitals in your territory that have the affected products to arrange return of the product, and return the affected product to: Stryker Orthobiologics, 67 Great Valley Parkway, Malvern, PA 19355. If you have any questions, feel free to contact the Associate Manager, Quality Assurance and Regulatory Compliance at 610-640-1775 x 5299.

Device

Device Recall Imbibe Aliquot Needle Bone Cement Needle
  • Model / Serial
    all lots of the Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle Catalog No.: 2110-0505, 2110-0506, 2110-0524, 2110-0529.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and country of: Canada.
  • Product Description
    Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Numbers: 2110-0505 Beveled Needle, 11 gauge x 4 inch || 2110-0524 Beveled Needle, 11 gauge x 6 inch || 2110-0506 Diamond Needle, 11 gauge x 4 inch || 2110-0529 Diamond Needle, 11 gauge x 6 inch || Intended Use: Can be used in either direct (or open) and percutaneous (or deep) delivery of bone cement.
  • Manufacturer
    Orthovita, Inc., dBA Stryker Orthobiologics.

Manufacturer

Orthovita, Inc., dBA Stryker Orthobiologics.
  • Manufacturer Address
    Orthovita, Inc., dBA Stryker Orthobiologics., 45 Great Valley Pkwy, Malvern PA 19355-1302
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA